Epirubicin: profile and news

Adjuvant Taxotere® and Herceptin® Effective for Breast Cancer ... 06 Mar 2006
FinHer Study have reported that Taxotere® (docetaxel) is superior to Navelbine® (vinorelbine) when given in addition to 5-FU, epirubicin and cyclophosphamide ... - Cancer Consultants (press release),

Addition of Ellence® to Standard Chemotherapy Does Not Improve ... Mar 2, 2006
According to an article recently published in the Journal of Clinical Oncology, the addition of the chemotherapy agent Ellence® (epirubicin) to the standard ... - Cancer Consultants (press release),

YM's Breast-Cancer Drug is Fast-Tracked Feb 13, 2006
...drug application will likely be approved or rejected in six months' time -- to the new treatment, which is intended for use with epirubicin/cyclophosphamide in ... - International News Service,

Intensive Therapy May Benefit Women With Breast Cancer of a Poor ... Feb 14, 2006
NEW YORK FEB 13, 2006 (Reuters Health) - An aggressive approach to chemotherapy consisting of adjuvant dose-intensive epirubicin and cyclophosphamide ... - Cancerpage.com,

Optimising Herceptin-based Therapy in HER2-positive Metastatic ... Feb 22, 2006
With a view to improving cardiac safety, the HERCULES trial researchers evaluated the addition of trastuzumab to epirubicin/cyclophosphamide. ... - DG News

YM BioSciences Receives FDA Fast Track Designation for Tesmilifene ... Feb 13, 2006
The trial compares tesmilifene combined with epirubicin/cyclophosphamide against epirubicin/cyclophosphamide alone in women with rapidly progressing metastatic ... - DG News

Adjuvant Docetaxel More Effective Than Vinorelbine for Early ... Feb 23, 2006
NEW YORK FEB 22, 2006 (Reuters Health) - Docetaxel is more effective than vinorelbine when administered prior to fluorouracil, epirubicin and cyclophosphamide ... - Cancerpage.com,

What Can Xeloda (capecitabine) Add to Neoadjuvant Chemotherapy? ... Feb 22, 2006
...group neoadjuvant phase 3 study GEPARQUATTRO, which is evaluating sequential and combination XT 900/75 mg/m 2 after four cycles of epirubicin/cyclophosphamide. ... - DG News

Adjuvant Docetaxel or Vinorelbine with or without Trastuzumab for ... Feb 22, 2006
...negative cancer to receive three cycles of docetaxel or vinorelbine, followed by (in both groups) three cycles of fluorouracil, epirubicin, and cyclophosphamide ... - New England Journal of Medicine (subscription),

Recurrence-Free Survival Improved with Taxotere® Compared to ... Feb 23, 2006
Both groups were then treated with the chemotherapy agents 5-fluorouracil, epirubicin, and cyclophosphamide. Of these patients, 232 were HER2-positive. ... - Cancer Consultants (press release),

Lamivudine Curbs Hepatitis B Virus Reactivation in Liver Cancer Feb 9, 2006
Patients using epirubicin and cisplatin at monthly intervals were randomized to receive or not receive lamivudine (100 mg daily) from the start of TACL. ... - Cancerpage.com,

Other information

Indication
For use as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer

Pharmacology
Epirubicin is an antineoplastic in the anthracycline class. General properties of drugs in this class include: interaction with DNA in a variety of different ways including intercalation (squeezing between the base pairs), DNA strand breakage and inhibition with the enzyme topoisomerase II. Most of these compounds have been isolated from natural sources and antibiotics. However, they lack the specificity of the antimicrobial antibiotics and thus produce significant toxicity. The anthracyclines are among the most important antitumor drugs available. Doxorubicin is widely used for the treatment of several solid tumors while daunorubicin and idarubicin are used exclusively for the treatment of leukemia. Epirubicin may also inhibit polymerase activity, affect regulation of gene expression, and produce free radical damage to DNA. Epirubicin possesses an antitumor effect against a wide spectrum of tumors, either grafted or spontaneous. The anthracyclines are cell cycle-nonspecific.

Mechanism Of Action
Epirubicin has antimitotic and cytotoxic activity. It inhibits nucleic acid (DNA and RNA) and protein synthesis through a number of proposed mechanisms of action: Epirubicin forms complexes with DNA by intercalation between base pairs, and it inhibits topoisomerase II activity by stabilizing the DNA-topoisomerase II complex, preventing the religation portion of the ligation-religation reaction that topoisomerase II catalyzes. It also interferes with DNA replication and transcription by inhibiting DNA helicase activity.

Drug Category
Antineoplastic Agents; ATC:L01DB03

Brand Names/Synonyms
4'-Epiadriamycin; 4'-Epidoxorubicin; CCRIS 2261; Ellence; Epi-Dx; Epiadriamycin; Epidoxorubicin; Epirubicin; Epirubicina [Inn-Spanish]; Epirubicina [Spanish]; Epirubicine [French]; Epirubicine [Inn-French]; Epirubicinum [Inn-Latin]; Epirubicinum [Latin]; HSDB 6962; IMI 28; Pharmorubicin Pfs; Pidorubicina [Inn-Spanish]; Pidorubicine [Inn-French]; Pidorubicinum [Inn-Latin]; Ridorubicin; WP 697

Dosage Forms
POWDER FOR SOLUTION; SOLUTION

Absorption
100%

Interactions
-->Interactions for Epirubicin:

ELLENCE when used in combination with other cytotoxic drugs may show on-treatment additive toxicity, especially hematologic and gastrointestinal effects.

Concomitant use of ELLENCE with other cardioactive compounds that could cause heart failure (e.g., calcium channel blockers), requires close monitoring of cardiac function throughout treatment.

There are few data regarding the coadministration of radiation therapy and epirubicin. In adjuvant trials of epirubicin-containing CEF-120 or FEC-100 chemotherapies, breast irradiation was delayed until after chemotherapy was completed. This practice resulted in no apparent increase in local breast cancer recurrence relative to published accounts in the literature. A small number of patients received epirubicin-based chemotherapy concomitantly with radiation therapy but had chemotherapy interrupted in order to avoid potential overlapping toxicities. It is likely that use of epirubicin with radiotherapy may sensitize tissues to the cytotoxic actions of irradiation. Administration of ELLENCE after previous radiation therapy may induce an inflammatory recall reaction at the site of the irradiation.

Epirubicin is extensively metabolized by the liver. Changes in hepatic function induced by concomitant therapies may affect epirubicin metabolism, pharmacokinetics, therapeutic efficacy, and/or toxicity.

Cimetidine increased the AUC of epirubicin by 50%. Cimetidine treatment should be stopped during treatment with ELLENCE.

Drug-Laboratory Test Interactions

There are no known interactions between ELLENCE and laboratory tests.

Chemical IUPAC Name
10-(4-amino-5-hydroxy-6-methyl-oxan-2-yl)oxy-6,8,11-trihydroxy-8-(2-hydroxyacetyl)-1-methoxy-9,10-dihydro-7H-tetracene-5,12-dione

Chemical Formula
C27H29NO11

Half Life
half-lives for the alpha, beta, and gamma phases of about 3 minutes, 2.5 hours and 33 hours, respectively

Drug Type
Approved Drug

# Accession No
APRD00361

CAS Registry Number
56420-45-2